WO2007018114A1 - Implant très peu invasif permettant d’ouvrir et d’agrandir un espace d’apophyse épineuse et procédé d’agrandissement percutanée d’espace d’apophyse épineuse avec celui-ci - Google Patents
Implant très peu invasif permettant d’ouvrir et d’agrandir un espace d’apophyse épineuse et procédé d’agrandissement percutanée d’espace d’apophyse épineuse avec celui-ci Download PDFInfo
- Publication number
- WO2007018114A1 WO2007018114A1 PCT/JP2006/315382 JP2006315382W WO2007018114A1 WO 2007018114 A1 WO2007018114 A1 WO 2007018114A1 JP 2006315382 W JP2006315382 W JP 2006315382W WO 2007018114 A1 WO2007018114 A1 WO 2007018114A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- spacer
- spinous processes
- interspinous
- screw
- region
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
Definitions
- the present invention relates to a minimally invasive implant for the purpose of opening between spinous processes, and more particularly to an interspinous spacer for expanding a spinal canal.
- the spinal canal is a longitudinal cylindrical space in the center of the spine (vertebra), in which the spinal cord and the tail (nerve) are contained and firmly protected.
- Spinal canal stenosis in which the spinal canal is narrowed due to various causes such as deformation of bone, cartilage, ligaments, etc., and the nerves inside it are compressed, the number of patients is increasing with the aging society. It is an increasing social issue
- lumbar spinal canal stenosis is caused by deformity and thickening of the lumbar intervertebral joints, degeneration and swelling of the intervertebral disc that is soft tissue, and thickening of the ligaments.
- Symptoms are typically gait disturbances such as neurological intermittent claudication, which is characterized by the fact that the lower limbs do not appear forward after walking for about a few minutes, and that they can walk again after crouching for a while. .
- Lumbar spinal canal stenosis is known to be anatomically reduced and symptomatically reduced by bending the lumbar spine by squatting or riding a bicycle.
- Conservative treatment methods include drug therapy that administers drugs that increase vascular dilation or blood flow around the nerve root or tail, and dura mater.
- ultrasonic therapy to improve analgesia, muscle spasticity, and blood circulation 'hot pack'
- There is physical therapy such as therapy.
- surgical therapies to counter this conservative treatment, such as laminectomy and enlarged fenestration. Neural decompression was a technique that has been used in the past.
- Laminectomy and enlarged fenestration techniques require the patient to undergo general anesthesia because of the surgical invasion of the patient to repair the lumbar stenosis. This technique can also put patients at risk of bleeding and serious complications and requires hospitalization in the ward for days to weeks after surgery. Therefore, this technique can further exacerbate the symptoms, especially when the patient is elderly and the patient is elderly.
- Patent Literature 1 Non-Patent Literature 1
- Patent Document 2 As a spacer between spinous processes, a spacer inserted between spinous processes using a guide pin and an obturator is known (Patent Document 2). These minimally invasive procedures can be operated with the use of local anesthesia, reducing the recovery period, reducing the risk of serious complications with little bleeding, and for patients. Since the cost of treatment can be lower, it is desirable to be able to treat spinal stenosis using minimally invasive procedures.
- Patent Document 1 JP 2005-517467
- Patent Document 2 International Publication No.WO 2005Z072301
- Non-Patent Document 1 Surgery for spine and spinal nerve 6 (1): 120-123, 2004 "Experience in treatment of lumbar spinal canal stenosis with interspinous process spacer (Sten-XTM) with local anesthesia"
- FIG. Figure 1 shows an overall schematic diagram of a conventional spacer device and an example of its use.
- A-1) is a completed assembly of the spacer device
- A-2) is one of the spacer devices.
- B- 1 shows the state before and after installing the spacer device.
- the conventional spacer device 30 has a wing portion 32 with a spacer part 31 sandwiched between them, as shown in FIG. 1 (A-2). As shown, one wing is removable.
- such a spacer device is arranged between the narrowed spinous processes, and can expand and fix between the spinous processes.
- the spacer device 30 is incised in a part of the patient's back by surgical operation, and exfoliates the paraspinal muscles to expose the spinous processes and interspinous ligaments ( Fig. 2 (a))
- a guide pin (guide pin) is provided at the skin incision site. After inserting, the obturator covering it is inserted, the spine process is expanded with this obturator, and finally the spacer is inserted.
- This obturator has a large diameter, thereby fulfilling the function of constructing a passage from the skin incision site to the space between the spinous processes into which the spacer is inserted.
- the present invention aims to achieve a minimally invasive treatment method for spinal canal stenosis, minimizing skin incision, and paraspinal muscles to the spine.
- a treatment device that can easily place the interspinous spacer without removing it from the skin. The purpose is to provide.
- the present inventor is a doctor who specializes in organ therapy, and after many clinical experiences with spinal stenosis, invented the interspinous process spacer according to the present invention, and produced various prototypes. Production ⁇ Completed with improvements.
- an interspinous process spacer includes a substantially conical screw part screwed between the spinous processes, and a part of the spacer formed in the longitudinal direction of the screw part.
- a head that can be appropriately engaged with a tool or that can be appropriately connected with a connecting member, and has a through hole in a part of the screw, a part of a spacer, and an axis of the head.
- the head that can be appropriately engaged with the tool or can be appropriately connected with the connecting member is, for example, a hole for a hexagonal screwdriver tool.
- a screwdriver tool the interspinous process spacer of the present invention can be pushed in while rotating from the small incision site to the internal spinous process.
- the interspinous process spacer of the present invention can be guided between the spinous processes by applying a force from the small incision site to the internal spinous processes.
- the screw portion of the interspinous spacer according to the present invention has a substantially radial outer contour or a circular conical shape at the tip. More preferably, the screw portion of the interspinous spacer according to the present invention is not a mere screw but is formed as an interference screw.
- the interspinous process spacer of the present invention is a force that advances in the skin and muscles of the patient's back by rotating the screw like a drill.
- the tip of the screw part is rather sharp.
- a round cone with an obtuse tip has a risk of incorrect insertion into the spinal canal. Less, it can be eliminated.
- a cross section of a part of the spacer of the interspinous process spacer may be circular, elliptical, substantially triangular, substantially rectangular, or polygonal. As described above, when a part of the screw passes between the spinous processes, a part of the spacer is sandwiched, and the adjacent spinous processes are enlarged and fixed.
- the spacer part can be easily sandwiched between the spinous processes regardless of the state in which the screw part passes between the spinous processes. Is possible.
- the cross section of a part of the spacer is approximately triangular or approximately quadrangular, the area to be joined to the adjacent spinous process is larger than that of a circular or elliptical shape. Can be sandwiched between.
- the outer shape of the entire interspinous spacer according to the present invention preferably has an elliptical shape. This is because, from the anatomical form, the interspinous process spacer 1 is easier to fit between the vertebral arches if it is elliptical as a whole.
- the diameter of a part of the spacer is larger than the diameters of the screw part and the head part. It is preferable that the cross-section in the longitudinal direction of the through hole has a substantially spindle shape.
- the screw part and a part of the spacer of the interspinous spacer according to the present invention have a ceramic material and biological activity in which alumina, zirconia, hydroxyapatite, calcium phosphate force is also selected. It is preferably made of a calcium phosphate-based glass material, a resin material, a plastic material, or a metal material selected from stainless steel, titanium, titanium alloy.
- a through hole formed in the axial center of the screw part and a part of the spacer is used as an insertion hole of the guide member.
- the position where the spinal canal is narrowed is confirmed by fluoroscopic techniques such as X-rays,
- the interspinous process spacer of the present invention is embedded between adjacent thoracic vertebrae and Z or lumbar spinous processes by the above-described method of percutaneously expanding between the spinous processes. Is preferred.
- interspinous process spacer In the interspinous process spacer according to the present invention, expansion between the spinous processes and insertion of the spacer are achieved in one step by compositing the screw part and a part of the spacer. Furthermore, since the interspinous spacer can be inserted and placed percutaneously even under local anesthesia, there is an effect that a simple operation can be performed in a minimally invasive manner.
- FIG. 3 shows an outline drawing of the interspinous spacer according to the present invention.
- Fig. 3 (b) Plane As shown in the figure, the interspinous process spacer of the present invention is engaged with a substantially conical screw part 2, a spacer part 3 formed in the longitudinal direction of the screw part, and a hexagonal screwdriver.
- the head 4 is provided with a hexagonal screwdriver hole 6, a screw part 2, a spacer part 3, and a guide wire insertion hole 5 penetrating through the axis of the head 4.
- the outer contour of the plan sectional view of the interspinous spacer is substantially elliptical! /. It is easy to fit between vertebral arches from clinical experience.
- the screw portion 2 of the interspinous spacer 1 has a substantially radial outer contour. This is because when the screw part 2 passes between the spinous processes, the outer contour of the radiation shape can widen the space between the spinous processes, making it easy for the spacer part 3 to fit between the spinous processes. It is. Further, the cross section of the spacer part 3 of the interspinous spacer 1 is formed in a circular shape so that the entire part of the spacer is cylindrical. This is because, even if the screw part 2 passes between the spinous processes at any angle, the spacer part 3 can be stably fitted between the spinous processes.
- the interspinous process spacer of the present invention is provided with a hexagonal screwdriver hole 6 so that the interspinous process spacer of the present invention can be rotated from a small incision while rotating the interspinous process spacer of the present invention. It can be pushed between the inner spinous processes.
- the interspinous process spacer of the present invention is provided with the guide wire insertion hole 5 so that it can be connected to the guide wire, and between the site where the guide wire is cut small and the internal spinous process. By inserting it with force, the spacer can be guided between the spinous processes along the guide wire.
- Fig. 4 (a) shows a cross-sectional view of the spinal canal. 10 is a spinous process, 11 is a vertebral body, and 12 is a vertebral foramen. Finally, as shown in FIG. 4B, the spacer portion of the interspinous process spacer 1 is sandwiched between the adjacent spinous processes 11.
- FIG. 5 shows a procedure for surgery using the interspinous process spacer according to the present invention.
- a small incision force guide wire 7 on the patient's back is inserted, and the guide wire 7 is inserted between the spinous processes 10.
- FIG. 5 (b) one end of the inserted guide wire 7 is passed through the guide wire insertion hole penetrating the shaft center of the interspinous spacer 1 according to the present invention.
- hex driver 8 is inserted into the spinous process.
- Fig. 6 (a) shows a side sectional view of the spinal canal
- Figs. 6 (b) and (c) show how the interspinous spacer according to the present invention is attached to the spinal canal.
- Show. 20 is a thickened yellow ligament
- 21 shows the bulging of the intervertebral disc.
- FIG. 6 (a) shows that the spinal canal is in a stenotic state, and as shown in FIG. 6 (b), the spinal canal is expanded by the interspinous process spacer according to the present invention. OK.
- the present invention may be practiced in specific ways other than those set forth herein without departing from the scope and essential characteristics of the invention.
- the interspinous process spacer and the method of percutaneously expanding between spinous processes according to the present invention are used to expand and fix between adjacent spinous processes.
- the present invention may not be applicable to create a space in another body tissue (enlarge and fix the distance between bones).
- This embodiment is to be considered in all respects without limitation, and all changes that come within the meaning and range of equivalency of the claims are intended to be embraced therein.
- FIG. 7 shows an external view of the interspinous spacer 1 of the first embodiment.
- the interspinous process spacer 1 of Example 1 was prepared by scraping the central part of a titanium ellipsoidal sphere to produce a spacer part 3, and providing a screw blade on one side surface to attach the screw part 2. I am making it.
- the dimensions (length and diameter) of the spacer part 3 vary depending on the condition between the spinous processes of the affected area, and Fig. 7 shows only an example of the dimensions.
- the tip portion of the screw portion 2 has a hemispherical force in FIG. 7, which may have a rounded cone shape. Also, the connection between the screw part 2 and the spacer part 3 is shown in FIG. As shown by the arrow in FIG. 8, the end side of the spacer part 3 may be spread adjacent to the crown side of the screw part 2 without any step.
- the screw pitch of the screw part 2 is about 1 to 2 mm, and the screw blades are made to protrude from the outer contour of the radiation shape of the screw part 2.
- 9 1 to 94 show a perspective view, a plan view, a right side view, and a left side view of the interspinous process spacer of Example 1, respectively.
- Symptoms are alleviated by bending the lumbar spine, and obstructive arteriosclerosis is denied.
- the size (diameter) of the spacer of the interspinous spacer is determined from the X-ray side view of the sitting position 'maximum lumbar anteversion (actual measurement). .
- the distance between the upper joint processes is measured with a standing front X-ray or CT image to determine the total length of the interspinous process spacer. Also, the guide pin insertion point and angle are measured by CT image.
- Protocols of actual surgical procedures are shown in the following procedures (a) to (i).
- the interspinous spacer according to the present invention can be expected to be used as a medical instrument useful for surgical treatment for spinal canal stenosis.
- FIG. 1 An overall schematic diagram and an example of use of a conventional spacer device are shown.
- FIG. 3 is a diagram showing a shape of an embodiment of the interspinous process spacer according to the present invention.
- A Front view,
- B Plan view,
- c Rear view.
- FIG. 4 (a) is a cross-sectional view of the spinal canal, and (b) shows a state in which the interspinous spacer 1 according to the present invention is attached to the spinal canal.
- FIG. 5 shows the procedure of the operation using the interspinous process spacer according to the present invention.
- FIG. 6 (a) is a side sectional view of the spinal canal, and (b) and (c) show a state in which the interspinous process spacer 1 according to the present invention is attached to the spinal canal.
- FIG. 7 shows an external view of a spacer between spinous processes of Example 1.
- FIG. 8 shows a state in which the end side of the spacer portion spreads and is adjacent to the crown side of the screw portion without any step in the interspinous process spacer 1 of Example 1.
- FIG. 9-1 is a perspective view of the interspinous process spacer of Example 1.
- FIG. 9-2 is a plan view of the interspinous process spacer 1 of Example 1.
- FIG. 9-3 shows a right side view of the interspinous process spacer 1 of Example 1.
- FIG. 9-4 A left side view of the interspinous spacer 1 of Example 1 is shown. Explanation of symbols
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- Orthopedic Medicine & Surgery (AREA)
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- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
L’invention propose de réaliser un procédé de thérapie très peu invasive de sténose de canal spinal à l’aide d’un dispositif thérapeutique capable de placer de manière stationnaire une entretoise interspinale sans faire appel à une grande incision cutanée ni une incision des tissus ligamenteux et également sans devoir détacher le muscle paraspinal de la colonne vertébrale. Elle concerne alors une entretoise interspinale comprenant une zone de vis conoïde (2) à visser dans un espace d’apophyse épineuse; une zone d’entretoise (3) disposée dans la direction longitudinale de la zone de vis (2) ; une zone de tête (4) capable de se solidariser librement avec un outil de façon arbitraire ; et un trou traversant (5) passant par le centre axial de la zone de vis (2), de la zone d’entretoise (3) et de la zone de tête (4). L’espace d’apophyse épineuse peut être agrandi en douceur en vissant la zone de vis (2) dans l’espace d’apophyse épineuse. La zone d’entretoise (3) se trouve pincée lors du passage de la zone de vis (2) à travers l’espace d’apophyse épineuse pour ainsi agrandir et fixer les espaces d’apophyse épineuse adjacents. L’entretoise interspinale peut être guidée vers une position interspinale par insertion d’un élément de guidage dans le trou traversant (5) aménagé le long du centre axial de la zone de vis (2) et de la zone d’entretoise (3) et par pénétration dans le corps le long de l’élément de guidage.
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/990,291 US8277487B2 (en) | 2005-08-11 | 2006-08-03 | Method of percutaneously enlarging processus spinosus interspace using minimally invasive implant |
EP06782242.9A EP1920719B1 (fr) | 2005-08-11 | 2006-08-03 | Implant très peu invasif permettant d'ouvrir et d'agrandir un espace entre apophyses épineuses |
JP2007529523A JP4797174B2 (ja) | 2005-08-11 | 2006-08-03 | 棘突起間の開大を目的とした低侵襲インプラントとそれを用いて棘突起間を経皮的に拡大する方法 |
US13/596,413 US8500779B2 (en) | 2005-08-11 | 2012-08-28 | Minimally-invasive implant for opening and enlargement of processus spinosus interspace |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2005232807 | 2005-08-11 | ||
JP2005-232807 | 2005-08-11 |
Related Child Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/990,291 A-371-Of-International US8277487B2 (en) | 2005-08-11 | 2006-08-03 | Method of percutaneously enlarging processus spinosus interspace using minimally invasive implant |
US13/596,413 Continuation US8500779B2 (en) | 2005-08-11 | 2012-08-28 | Minimally-invasive implant for opening and enlargement of processus spinosus interspace |
Publications (1)
Publication Number | Publication Date |
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WO2007018114A1 true WO2007018114A1 (fr) | 2007-02-15 |
Family
ID=37727299
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/JP2006/315382 WO2007018114A1 (fr) | 2005-08-11 | 2006-08-03 | Implant très peu invasif permettant d’ouvrir et d’agrandir un espace d’apophyse épineuse et procédé d’agrandissement percutanée d’espace d’apophyse épineuse avec celui-ci |
Country Status (4)
Country | Link |
---|---|
US (2) | US8277487B2 (fr) |
EP (1) | EP1920719B1 (fr) |
JP (1) | JP4797174B2 (fr) |
WO (1) | WO2007018114A1 (fr) |
Cited By (7)
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JP2008253311A (ja) * | 2007-03-31 | 2008-10-23 | Kobe Univ | 棘突起間スペーサー,抜去用ドライバー,固定用内ネジ,手術用キットおよび棘突起間スペーサーの抜き去り方法 |
EP2134275A2 (fr) * | 2007-03-26 | 2009-12-23 | Globus Medical, Inc. | Espaceur de l'apophyse épineuse latéral |
WO2011111301A1 (fr) * | 2010-03-09 | 2011-09-15 | 国立大学法人神戸大学 | Implant d'apophyse inter-épineux |
JP2012520120A (ja) * | 2009-03-13 | 2012-09-06 | スパイナル シンプリシティ エルエルシー | 棘突起間インプラントおよび融合ケージスペーサー |
WO2013005532A1 (fr) * | 2011-07-04 | 2013-01-10 | テルモ株式会社 | Ensemble implant |
US8758412B2 (en) | 2010-09-20 | 2014-06-24 | Pachyderm Medical, L.L.C. | Integrated IPD devices, methods, and systems |
WO2015001661A1 (fr) * | 2013-07-05 | 2015-01-08 | テルモ株式会社 | Outil d'assistance médicale, outil médical, et procédé de mesure de distance |
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US8241330B2 (en) | 2007-01-11 | 2012-08-14 | Lanx, Inc. | Spinous process implants and associated methods |
US9055981B2 (en) | 2004-10-25 | 2015-06-16 | Lanx, Inc. | Spinal implants and methods |
US9265532B2 (en) | 2007-01-11 | 2016-02-23 | Lanx, Inc. | Interspinous implants and methods |
US8172878B2 (en) | 2008-08-27 | 2012-05-08 | Yue James J | Conical interspinous apparatus and a method of performing interspinous distraction |
EP2413825A4 (fr) | 2009-03-31 | 2013-12-11 | Lanx Inc | Implants pour apophyse épineuse et procédés associés |
US9149306B2 (en) | 2011-06-21 | 2015-10-06 | Seaspine, Inc. | Spinous process device |
US11812923B2 (en) | 2011-10-07 | 2023-11-14 | Alan Villavicencio | Spinal fixation device |
DE202018004933U1 (de) | 2018-10-24 | 2018-11-19 | Jacek Gawda | Prismatische interspinöse Vorrichtung zur Abstützung der Dornfortsätze von zwei benachbarten Wirbeln zur Therapie und Vorbeugung der stellungsbedingten Erkrankungen und Verformungen der Wirbelsäule bei Tieren. |
KR102231234B1 (ko) * | 2019-07-09 | 2021-03-24 | 충남대학교산학협력단 | 외과용 다각 잠김 나사 제거 장치 |
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EP2134275A4 (fr) * | 2007-03-26 | 2013-01-23 | Globus Medical Inc | Espaceur de l'apophyse épineuse latéral |
EP2134275A2 (fr) * | 2007-03-26 | 2009-12-23 | Globus Medical, Inc. | Espaceur de l'apophyse épineuse latéral |
US9545267B2 (en) | 2007-03-26 | 2017-01-17 | Globus Medical, Inc. | Lateral spinous process spacer |
JP2008253311A (ja) * | 2007-03-31 | 2008-10-23 | Kobe Univ | 棘突起間スペーサー,抜去用ドライバー,固定用内ネジ,手術用キットおよび棘突起間スペーサーの抜き去り方法 |
JP2012520120A (ja) * | 2009-03-13 | 2012-09-06 | スパイナル シンプリシティ エルエルシー | 棘突起間インプラントおよび融合ケージスペーサー |
US20120330360A1 (en) * | 2010-03-09 | 2012-12-27 | National University Corporation Kobe University | Inter-spinous process implant |
JP5272279B2 (ja) * | 2010-03-09 | 2013-08-28 | 国立大学法人神戸大学 | 棘突起間インプラント |
US9101409B2 (en) | 2010-03-09 | 2015-08-11 | National University Corporation Kobe University | Inter-spinous process implant |
WO2011111301A1 (fr) * | 2010-03-09 | 2011-09-15 | 国立大学法人神戸大学 | Implant d'apophyse inter-épineux |
US8758412B2 (en) | 2010-09-20 | 2014-06-24 | Pachyderm Medical, L.L.C. | Integrated IPD devices, methods, and systems |
US9084641B2 (en) | 2010-09-20 | 2015-07-21 | Pachyderm Medical, L.L.C. | Integrated IPD devices, methods, and systems |
WO2013005532A1 (fr) * | 2011-07-04 | 2013-01-10 | テルモ株式会社 | Ensemble implant |
WO2015001661A1 (fr) * | 2013-07-05 | 2015-01-08 | テルモ株式会社 | Outil d'assistance médicale, outil médical, et procédé de mesure de distance |
Also Published As
Publication number | Publication date |
---|---|
US20090099603A1 (en) | 2009-04-16 |
US8277487B2 (en) | 2012-10-02 |
JPWO2007018114A1 (ja) | 2009-02-19 |
JP4797174B2 (ja) | 2011-10-19 |
EP1920719A1 (fr) | 2008-05-14 |
EP1920719A4 (fr) | 2011-01-26 |
EP1920719B1 (fr) | 2015-12-02 |
US8500779B2 (en) | 2013-08-06 |
US20130060286A1 (en) | 2013-03-07 |
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